Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00710034

Recruitment Status :
Completed

First Posted : July 3, 2008

Results First Posted : December 6, 2017

Last Update Posted : December 6, 2017

Sponsor:

University of Minnesota - Clinical and Translational Science Institute

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for ...

Description

Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.

Time Frame

Week 1-12 post switching

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Using assigned product only. The numbers of subjects that were only using the assigned product were 40 and 37 for nicotine gum and oral tobacco respectively at week 12. Analysis was conducted from weeks 1-12 post-switching.

Arm/Group Title

Nicotine Gum

Snus

Arm/Group Description:

Nicotine replacement therapy
...

Oral tobacco

Arm/Group Description:

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Overall Number of Participants Analyzed

40

37

Mean (Standard Deviation)

Unit of Measure: units on a scale

Baseline Scores

4.17
(5.01)

5.01
(5.14)

Week 12 Scores

5.57
(6.05)

5.73
(6.24)

5.Secondary Outcome

Title

Product Effect on Biomarkers of Exposure and Toxicity

Description

Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and it...

Description

Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).